1. What are the general ideas and principles for the revision of the Measures for the Supervision and Administration of the Operation of Medical Devices (hereinafter referred to as the Measures)?
The safety and effectiveness of medical devices are related to the lives and health of the people, and the management process of medical devices directly affects the quality and safety of products. As one of the supporting regulations of the Regulations, the general idea of the revision of the "Business Measures" is mainly to grasp the following four points: First, to implement the system of registrant and recorder of medical devices, and strengthen the quality and safety responsibility of the whole life cycle. The second is to strictly implement the spirit of the reform of "delegating supervision and service", and simplify the requirements of relevant declaration materials and procedures. Third, we will clarify oversight and inspection powers and strengthen oversight measures. Fourth, we increased oversight measures to address the lack of oversight tools. Fifth, we will strengthen oversight of law enforcement and promote fair and clean law enforcement.
In order to reflect the latest supervision philosophy, the new Business Measures adhere to the following revised principles: First, adhere to the principle of classified management. Management of the first type of medical devices do not need to be licensed and put on record, management of the second type of medical devices to implement the record management, the safety and effectiveness of the product is not affected by the circulation process of the second type of medical devices can be exempted from the operation of the record, management of the third type of medical devices to implement licensing management. Second, adhere to the principle of corporate principal responsibility. In order to highlight the responsibility of enterprise operation, it is required that medical device business enterprises should establish quality management systems and quality control measures covering the whole process of quality management in accordance with laws and regulations and medical device business quality management standard requirements, and make relevant records to ensure that business conditions and business activities continue to meet the requirements. Third, adhere to the principle of strict supervision. We will enrich and improve regulatory measures to promote the implementation of regulatory responsibilities through a comprehensive application of systems such as random inspection, flight inspection, responsibility interview, safety alert and credit file. Fourth, adhere to the principle of traceability. It stipulates that enterprises shall establish and implement purchase inspection record system. Enterprises engaged in wholesale business of Class II and Class III medical devices and retail business of Class III medical devices shall establish a sales record system.
2. What are the requirements of the Measures on the quality management of enterprise operations?
On the one hand, the Measures further strengthen the quality responsibility of enterprises. It requires enterprises engaged in the operation of medical devices to establish quality management systems and quality control measures covering the whole process of procurement, acceptance, storage, sales, transportation, and after-sales service in accordance with laws and regulations and the requirements of medical device management quality management standards, and make relevant records to ensure that business conditions and business activities continue to meet the requirements. At the same time, medical device trading enterprises shall establish a quality management self-inspection system, carry out self-inspection in accordance with the requirements of the medical device trading quality management standards, and submit the previous year's self-inspection report to the local city and county departments responsible for drug supervision and administration before March 31 each year. On the other hand, they should pay more attention to the quality management of the whole process of operation. First, medical device trading enterprises should be required to purchase medical devices from legally qualified registrants, recordholders and operating enterprises, and strictly control the qualification examination of the purchase and sales links to ensure the legal circulation of medical devices. Second, it highlights the record requirements of purchase inspection and sales links to ensure the traceability of products, and the unique identification system of medical devices should be implemented in accordance with relevant national regulations. Third, it emphasizes the storage and transportation requirements of low-temperature and refrigerated medical devices to ensure the quality of product transportation. Fourth, it puts forward the requirements on the after-sales service of the operating enterprises to ensure the safety of the use of the products.
3. What measures should be adopted in the Measures for Operation to strengthen supervision?
The new Business Measures will be problem-oriented, fully implement the "four strictest" requirements, and strengthen supervision through the following measures: First, implement classified and tiered management. According to the quality control of the medical device trading enterprises and the risk degree of the medical device products, the drug supervision and administration departments implement classification and classification management and dynamic adjustment. Second, annual inspection plans shall be formulated. The department responsible for drug supervision and administration at the city or county level divided into districts shall formulate an annual inspection plan, specify the focus of supervision, frequency, and coverage of inspection, and organize its implementation. Third, extended inspection shall be carried out. Drug supervisory and administrative departments may, according to the needs of quality and safety risk prevention and control of medical devices, conduct extended inspection on other relevant units and individuals that provide products or services for the trading activities of medical devices. Fourth, risk consultation, research, and judgment. Drug regulatory departments shall, based about supervision and inspection, product sampling inspection, adverse event monitoring, complaints and reports, and administrative punishment, carry out risk consultation, research, and judgment on a regular basis, and do a good job in the investigation, prevention, and control of hidden dangers of the quality and safety of medical devices. Fifth, the construction of credit files. The department in charge of drug supervision and administration at a city divided into districts shall establish and timely update the credit files of the enterprises dealing in medical devices within their jurisdiction.
4. What are the differences between wholesale and retail enterprises of medical devices, and what are the regulations on the sales of medical devices by registrants and archivists?
The difference between wholesale and retail of medical devices mainly lies in the difference of sales objects. Medical device wholesale refers to the operation of medical devices by selling medical devices to medical device manufacturers, medical device distributors, medical device users or other units with reasonable use requirements. Medical device retail refers to the operation of medical devices by selling medical devices directly to consumers for their personal use.
A registrant or filing person of a medical device may sell the medical device registered or filed by himself or entrust a medical device trading enterprise to sell it. Where a medical device registrant or filing person entrusts sales, it shall entrust a qualified medical device trading enterprise, and sign an entrustment agreement to define the rights and obligations of both parties.
5. What measures do the "Measures on Operation" include in implementing the spirit of the reform of "delegating supervision and service"?
In order to implement the reform spirit of "regulating and regulating services", the first is to cancel the provision of "copy of business license" and "other certification materials" when handling business license and filing. For those applying for the third type of business license and handling the second type of business filing procedures at the same time, submit the materials once and complete the on-site verification provisions simultaneously. For those who have obtained the business license of Class III medical devices and put them on record of Class II medical devices, they may be exempted from submitting relevant materials. Second, the original 30 working days will be adjusted to decide within 20 working days from the date of acceptance, shortening the time limit for processing. Third, the second type of medical devices whose product safety and effectiveness are not affected by the circulation process can be exempted from business filing. The State Medical Products Administration has formulated and published 13 kinds of products. It is not necessary to apply for business license or business filing for the registrant or recordholder of medical devices to sell their registered or filed medical devices at their domicile or production address, as well as institutions engaged in non-profit storage, allocation, and supply of contraceptive medical devices. 4. For the reissue of lost licenses, the provisions on publishing the loss statement in the media designated by the original license-issuing department have been cancelled.
Content source: State Medical Products Administration
